Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

Appendicitis Clinical Trial

— PERFECT  

Official title:

Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378868
• Other study ID #: HUS-PERFECT
• Secondary ID: 2019-002348-26
• Status: Completed
• Phase: Phase 4
• Start date: May 18, 2020
• Est. completion date: February 23, 2023

Study information

• Verified date: July 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effects of preoperative delay and antibiotics on perforation rate of appendix while waiting surgery for acute appendicitis. Patients with diagnosed acute appendicitis are randomized into two urgency groups: surgery within 8 hours or surgery within 24 hours. In addition, patients are randomized to either receive antibiotics while waiting or waiting without antibiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: February 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute appendicitis where surgery is planned. Diagnosis of appendicitis should be verified either by clinical diagnosis with Adult Appendicitis Score >=16 or by diagnostic imaging (CT-scan, MRI or ultrasound) showing appendicitis. All patients with symptoms at least 3 days should undergo diagnostic imaging before inclusion.

Exclusion Criteria:

• Complicated appendicitis according to diagnostic imaging. The following findings indicate complicated appendicitis: extraluminal air or extraluminal fecalith; fluid collection, abscess or phlegmon next to appendix; non-enhancement appendiceal wall on contrast enhanced CT-scan.

• Plasma C-reactive protein >=100

• Fever measured on emergency department over 38.5 degrees Celcius.

• Clinical generalized peritonitis or other reason that indicate immediate surgery

• Pregnancy, pregnancy test is taken from all fertile aged women before randomization

• Allergy to study antibiotics, or anaphylactic reaction after betalactam antibiotic or other contraindication for metronidazole or ongoing antibiotic treatment or patient is carrier of resistant bacteria. (This exclusion criteria are applicable only on randomization into antibiotic treatment arms)

• Missing written informed consent

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• Antibiotics, cefuroxime and metronidazole
Patient receives antibiotics while waiting appendectomy
• No antibiotics
No antibiotics are given while waiting surgery.

Other:
• urgent schedule
Patients can wait up to 8 hours for surgery.
• less urgent schedule
Patients can wait up to 24 hours for surgery.

Locations

Country	Name	City	State
Finland	HUS, Jorvi Hospital	Espoo
Finland	HUS, Meilahti Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Reid F, Choi J, Williams M, Chan S. Prospective evaluation of the Sunshine Appendicitis Grading System score. ANZ J Surg. 2017 May;87(5):368-371. doi: 10.1111/ans.13271. Epub 2015 Sep 1. — View Citation

Sammalkorpi HE, Mentula P, Leppaniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114. — View Citation

Shafi S, Aboutanos M, Brown CV, Ciesla D, Cohen MJ, Crandall ML, Inaba K, Miller PR, Mowery NT; American Association for the Surgery of Trauma Committee on Patient Assessment and Outcomes. Measuring anatomic severity of disease in emergency general surgery. J Trauma Acute Care Surg. 2014 Mar;76(3):884-7. doi: 10.1097/TA.0b013e3182aafdba. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complicated appendicitis	Surgical finding is complicated appendicitis (AAST Grade III-V)	during surgery
Secondary	Time of hospital stay	Time in hours from randomization to discharge from hospital	30 days from surgery
Secondary	Postoperative complications	complications are defined according to Clavien-Dindo classification	30 days from surgery
Secondary	Pain measured by numeric rating scale while waiting surgery	Pain is measured by numeric rating scale (NRS) every hour by patient, and area under NRS represents overall pain.	up to 36 hours
Secondary	Surgical site infections (SSI) and positive blood cultures	SSIs classified according to CDC classification: superficial incisional, deep incisional and organ/space infection. Blood cultures are obtained if patient has fever over 38.5 degrees Celcius.	within 30 days from randomization
Secondary	Conversions of laparoscopic surgeries to open surgery	All surgeries are started as laparoscopic surgery. Conversion means that operation is converted to open surgery during the same operation.	during the the first operation for acute appendicitis
Secondary	Gangrenous or perforated appendicitis according to pathological examination.	All specimens are sent to pathological examination and all pathological reports are reviewed	3 week after surgery
Secondary	Sunshine Appendicitis Grading System Score classification	Sunshine Appendicitis Grading System Score (range 0-4) for appendicitis. Higher score represents worse outcome	during surgery

External Links

•   Link for calculation of Adult Appendicitis Score